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Thu Apr 5 12:26:37 2001 UTC (23 years ago) by dpavlin
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smpc for veterina

1
2
3 <!--Section Begins--><br>
4
5
6
7
8
9
10 <div align="left">
11 <p style="text-align: left;">
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13
14
15 </p>
16 </div>
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26
27
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>AMPIVET</b><b><sup>® </sup></b><b>K</b>
33
34 </p>
35 </div>
36
37
38
39
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42
43
44
45
46
47
48 <div align="justify">
49 <p style="text-align: justify;">
50
51 suspension for intramammary administration against mastitis in the lactating cows
52
53 </p>
54 </div>
55
56
57
58
59
60
61
62
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67 <div align="justify">
68 <p style="text-align: justify;">
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72 </p>
73 </div>
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84
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86 <div align="justify">
87 <p style="text-align: justify;">
88
89 <b><i>Composition</i></b>
90
91 </p>
92 </div>
93
94
95
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98
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100
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102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 5 mL contain:
109
110 </p>
111 </div>
112
113
114
115
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118
119
120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
126
127 Cloxacillin as cloxacillin sodium 100 mg
128
129 </p>
130 </div>
131
132
133
134
135
136
137
138
139
140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 Ampicillin as ampicillin trihydrate 200 mg
147
148 </p>
149 </div>
150
151
152
153
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155
156
157
158
159
160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165 Base - white paraffin and liquid paraffin up to 5 mL
166
167 </p>
168 </div>
169
170
171
172
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175
176
177
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179
180
181 <div align="justify">
182 <p style="text-align: justify;">
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184
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186 </p>
187 </div>
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189
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195
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197
198
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200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Action</i></b>
204
205 </p>
206 </div>
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214
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217
218
219 <div align="justify">
220 <p style="text-align: justify;">
221
222 AMPIVET<sup>® </sup>K is a combination of semi-synthetic penicillins (ampicillin and cloxacillin) which inhibit cross-linking of peptoglycan threads and act bactericidally on the growing bacteria. It has antimicrobial action against major gram-positive and gram-negative pathogens: <i>Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Staphylococcus aureus, E. coli, Actinomyces pyogenes</i>, etc. Both penicillin ingredients exert an additive and partially synergistic effect. Given the resistance of bacterial beta-lactamase to cloxacillin, AMPIVET<sup>? </sup>K successfully treats inflammations caused by benzylpenicillin-resistant strains of staphylococci. Intramammary infusion has batericidal effect and does not cause local tissue irritation. The treatment should be long enough to achieve clinical cure.
223
224 </p>
225 </div>
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234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241
242
243 </p>
244 </div>
245
246
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253
254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260 <b><i>Indications</i></b>
261
262 </p>
263 </div>
264
265
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267
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270
271
272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Treatment of lactating cows against clinical and subclinical mastitis caused by ampicillin- and cloxacillin-sensitive gram-positive and gram-negative bacteria. AMPIVET<sup>® </sup>K is particularly indicated against udder inflammations caused by streptococci, staphylococci, <i>E. coli</i> and <i>Actinomyces pyogenes </i>species.
280
281 </p>
282 </div>
283
284
285
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288
289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298
299
300 </p>
301 </div>
302
303
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307
308
309
310
311
312
313
314 <div align="justify">
315 <p style="text-align: justify;">
316
317 <b><i>Contraindications</i></b>
318
319 </p>
320 </div>
321
322
323
324
325
326
327
328
329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336 AMPIVET<sup>® </sup>K should not be given to the cows during dry period.
337
338 </p>
339 </div>
340
341
342
343
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346
347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355
356
357 </p>
358 </div>
359
360
361
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365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 <b><i>Administration and dosage</i></b>
375
376 </p>
377 </div>
378
379
380
381
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384
385
386
387
388
389
390 <div align="justify">
391 <p style="text-align: justify;">
392
393 Immediately prior to administration of AMPIVET<sup>® </sup>K milk out the udder. Teat ends and orifices must be clean and disinfected. Introduce the tip of the injector into the beginning of the teat canal and slowly inject the contents.
394
395 </p>
396 </div>
397
398
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404
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409 <div align="justify">
410 <p style="text-align: justify;">
411
412
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414 </p>
415 </div>
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426
427
428 <div align="justify">
429 <p style="text-align: justify;">
430
431 After administration of AMPIVET<sup>® </sup>K gently massage the udder upward, from the teat to the udder base, to evenly distribute the drug over the milk cistern, through the canals and alveoli of the mammary gland.
432
433 </p>
434 </div>
435
436
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444
445
446
447 <div align="justify">
448 <p style="text-align: justify;">
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450
451
452 </p>
453 </div>
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455
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457
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461
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464
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466 <div align="justify">
467 <p style="text-align: justify;">
468
469 Inject the contents of one injector into each affected quarter in 12- hour intervals. Milk out the udder before each administration.
470
471 </p>
472 </div>
473
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477
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485 <div align="justify">
486 <p style="text-align: justify;">
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490 </p>
491 </div>
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499
500
501
502
503
504 <div align="justify">
505 <p style="text-align: justify;">
506
507 <b><i>Warnings, precautions and interactions</i></b>
508
509 </p>
510 </div>
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518
519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526 Manifestations of allergic reactions in the animals hypersensitive to penicillin antibiotics have been reported extremely rarely. Concurrent intramammary infusion of penicillins with systemic tetracycline or macrolide antibiotics is not recommended.
527
528 </p>
529 </div>
530
531
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540
541
542 <div align="justify">
543 <p style="text-align: justify;">
544
545
546
547 </p>
548 </div>
549
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555
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557
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559
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561 <div align="justify">
562 <p style="text-align: justify;">
563
564 If more animals in a herd are affected, it is recommended to perform sensitivity tests before the treatment.
565
566 </p>
567 </div>
568
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577
578
579
580 <div align="justify">
581 <p style="text-align: justify;">
582
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584
585 </p>
586 </div>
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599 <div align="justify">
600 <p style="text-align: justify;">
601
602 After removal of the protective cap, care should be taken not to contaminate tip of the injector.
603
604 </p>
605 </div>
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618 <div align="justify">
619 <p style="text-align: justify;">
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623 </p>
624 </div>
625
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629
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632
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635
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637 <div align="justify">
638 <p style="text-align: justify;">
639
640 <b><i>Withdrawal</i></b>
641
642 </p>
643 </div>
644
645
646
647
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649
650
651
652
653
654
655
656 <div align="justify">
657 <p style="text-align: justify;">
658
659 Meat, organs and other edible tissues - 0 days.
660
661 </p>
662 </div>
663
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669
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671
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675 <div align="justify">
676 <p style="text-align: justify;">
677
678
679
680 </p>
681 </div>
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690
691
692
693
694 <div align="justify">
695 <p style="text-align: justify;">
696
697 Milk - 3 days. Milk of the cows that are milked twice daily can be used after the sixth milking.
698
699 </p>
700 </div>
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713 <div align="justify">
714 <p style="text-align: justify;">
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718 </p>
719 </div>
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729
730
731
732 <div align="justify">
733 <p style="text-align: justify;">
734
735 <b><i>Storage</i></b>
736
737 </p>
738 </div>
739
740
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746
747
748
749
750
751 <div align="justify">
752 <p style="text-align: justify;">
753
754 Store in a cool place up to 15˚C. Keep away from children. Avoid freezing.
755
756 </p>
757 </div>
758
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769
770 <div align="justify">
771 <p style="text-align: justify;">
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775 </p>
776 </div>
777
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785
786
787
788
789 <div align="justify">
790 <p style="text-align: justify;">
791
792 <b><i>Shelf life</i></b>
793
794 </p>
795 </div>
796
797
798
799
800
801
802
803
804
805
806
807
808 <div align="justify">
809 <p style="text-align: justify;">
810
811 Denoted on the packaging (2 years).
812
813 </p>
814 </div>
815
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820
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822
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825
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827 <div align="justify">
828 <p style="text-align: justify;">
829
830
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832 </p>
833 </div>
834
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838
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845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849 <b><i>Legal category</i></b>
850
851 </p>
852 </div>
853
854
855
856
857
858
859
860
861
862
863
864
865 <div align="justify">
866 <p style="text-align: justify;">
867
868 On prescription only.
869
870 </p>
871 </div>
872
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880
881
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883
884 <div align="justify">
885 <p style="text-align: justify;">
886
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889 </p>
890 </div>
891
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898
899
900
901
902
903 <div align="justify">
904 <p style="text-align: justify;">
905
906 <b><i>Supply</i></b>
907
908 </p>
909 </div>
910
911
912
913
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915
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919
920
921
922 <div align="justify">
923 <p style="text-align: justify;">
924
925 Box with 12 injectors of 5 mL.
926
927 </p>
928 </div>
929
930
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933
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938
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940
941 <div align="justify">
942 <p style="text-align: justify;">
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946 </p>
947 </div>
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960 <div align="justify">
961 <p style="text-align: justify;">
962
963 <b><i>Manufacturer</i></b>
964
965 </p>
966 </div>
967
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978
979 <div align="justify">
980 <p style="text-align: justify;">
981
982 VETERINA Animal Health Ltd., Croatia
983
984 </p>
985 </div>
986
987
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995
996
997
998 <div align="left">
999 <p style="text-align: left;">
1000
1001
1002
1003 </p>
1004 </div>
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017 <div align="left">
1018 <p style="text-align: left;">
1019
1020
1021
1022 </p>
1023 </div>
1024
1025
1026
1027
1028
1029
1030
1031 <!--Section Ends-->
1032
1033
1034
1035
1036
1037
1038
1039

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